On 15 April 2013, the Supreme Court of the United States heard oral arguments in the case Association for Molecular Pathology, et. al., v. Myriad Genetics, et. al, hearing arguments over the question: are human genes patentable? The case, which has been litigated since 2009, specifically involves two genes, known as the BRCA1 and BRCA2 genes which are associated with an individual’s susceptibility to breast and ovarian cancer. KEI has filed several amicus briefs in this case and also provided other analysis and covered the case at the lower court levels, available here. More background on the harms that patenting of the BRCA1/2 genes have caused available here and here. While the Supreme Court heard arguments, Breast Cancer Action held a rally on the steps of the Court, with numerous patients and amici speaking (photos available here).
At oral arguments, Chris Hansen of the ACLU represented the petitioners, General Donald Verilli argued on behalf of the U.S. Government and Gregory Castanias of Jones Day represented Myriad Genetics. Highlights of the oral arguments included a resurrection of hypotheticals used at the Federal Circuit, including analogies between DNA to baseball bats as well as human organs such as a liver or kidney. Justice Alito created a new hypothetical regarding a plant in the Amazon that had medicinal value. Justice Kagan called the USPTO “patent happy.” Justice Breyer questioned Mr. Castanias as to whether a brief by Dr. Lander was wrong scientifically. Much of the discussions involved the patent eligibility of cDNA and the differences between cDNA and isolated DNA. Excerpts from the morning’s oral arguments are reproduced below. A decision is expected by the end of June when the Supreme Court term ends.
Oral Arguments of Counsel for Petitioners (Association for Molecular Pathology, et. al.)
Mr. Hansen began arguments by asserting that Myriad has invented nothing, and while deserving of credit for its discovery, it should not receive a patent reward. While noting that a process for discovering something new could be patented, the product of nature itself could not receive patent protection.
Justice Sotomayor asked why the diagnostic test itself had not been patented, to which Mr. Hansen explained that the tests are routine, but that they had in fact challenged some of the method patents which essentially involved a process of simply looking at the tested gene with a normal looking gene (and which had been invalidated by the Federal Circuit).
Justice Scalia then turned to the question of why the method for extracting or isolating the DNA had not been patented. Mr. Hansen answered “. . . the original methodology was patented, and is — is patentable. In fact, if they came up with a new process, it would be patentable. But it has — but that — it has been very freely licensed. In fact, the patent may now have expired. And so it’s used all over the country every day.”
Justice Alito posed a hypothetical regarding a plant found in the Amazon with medicinal purposes, such as to treat breast cancer, and had the following exchange:
MR. HANSEN: If there is no alteration, if we simply pick the leaf off of the tree and swallow it and it has some additional value, then I think it is not patentable. You might be able to get a method patent on it, you might be able to get a use patent on it, but you can’t get a composition patent. But as -JUSTICE ALITO: But you’re making — you keep making the hypotheticals easier than they’re intended to be. It’s not just the case of taking the leaf off the tree and chewing it. Let’s say if you do that, you’d have to eat a whole forest to get the — the value of this. But it’s extracted and — and reduced to a concentrated form. That’s not patent — that’s not eligible?
MR. HANSEN: No, that may well be eligible, because you have now taken what was in nature and you’ve transformed it in two ways. First of all, you’ve made it substantially more concentrated than it was in nature; and second, you’ve given it a function. If it doesn’t work in the diluted form but does work in a concentrated form, you’ve given it a new function. And the — by both changing its nature and by giving it a new function, you may well have patent -
JUSTICE ALITO: Well, when you concede that, then I’m not sure how you distinguish the isolated DNA here, because it has a different function. Will you dispute that? Isolated DNA has a very different function from the DNA as it exists in nature. And although the chemical composition may not be different, it — it certainly is in a different form. So what is the distinction?
MR. HANSEN: Well, I don’t think it has a new function, Your Honor, with respect. I believe that what — Myriad has proffered essentially three functions for the DNA outside the body as opposed to inside the body. The first is we can look at it. And that’s true, but that’s not really a new function. That’s simply the nature of when you extract something you can look at it better.
The second two rationales that Myriad has proffered are that it can be used as probes and primers. Three of the — three of lower court judges found that full-length DNA, which all of these patent claims include, cannot be used as probes and primers. But more important, finding a new use for a product of nature, if you don’t change the product of nature, is not patentable. If I find a new way of taking gold and making earrings out of it, that doesn’t entitle me to a patent on gold. If I find a new way of using lead, it doesn’t entitle me to a new — to a patent on lead.
Justice Kagan raised the question of whether incentives exist to isolate and discover genes with the reward of a patent. Mr. Hansen suggested that in this particular case, there was clear evidence of other scientist and researchers willing to do the work, leading to a lengthy discussion on the incentives issue:
MR. HANSEN: Well, we know that would not have happened in this particular case, Your Honor. We know that there were other labs looking for the BRCA genes and they had announced that they would not patent them if they were the first to find it. We also know that prior to the patent actually being issued, there were other labs doing BRCA testing and Myriad shut all that testing down. So we know in this particular case that problem would not have arisen. But the point of the whole — the whole point of the product of nature doctrine is that when you lock up a product of nature, it prevents industry from innovating and — and making new discoveries. That’s the reason we have the product of nature doctrine, is because there may be a million things you can do with the BRCA gene, but nobody but Myriad is allowed to look at it and that is impeding science rather than advancing it.JUSTICE SCALIA: But you still haven’t answered her question. Why? Why would a company incur massive investment if it — if it cannot patent?
MR. HANSEN: Well, taxpayers paid for much of the investment in Myriad’s work, but -
JUSTICE SCALIA: You’re still not answering the question.
MR. HANSEN: But — yeah. But I think scientists look for things for a whole variety of reasons, sometimes because they’re curious about the world as a whole; sometimes because -
JUSTICE SCALIA: Curiosity is your answer.
[. . .]
MR. HANSEN: Sometimes, because they want a Nobel Prize. Sometimes -
JUSTICE KAGAN: I thought you were going to say something else, Mr. Hansen, and I guess I — I hoped you were going to say something else, which is that, notwithstanding that you can’t get a patent on this gene, that — that there are still, you know, various things that you could get a patent on that would make this kind of investment worthwhile in the usual case. But if that’s the case, I want to know what those things are rather than you’re just saying, you know, we’re supposed to leave it to scientists who want Nobel Prizes.
And I agree that there are those scientists, but there are also, you know, companies that do investments in these kinds of things that you hope won’t just shut them down.
MR. HANSEN: Let me give a specific example that may be helpful in doing a better job of answering the question. One of the — one of the amici has worried a lot about whether a decision for the Petitioners in this case would invalidate recombinant DNA. Recombinant DNA is in fact what all the major innovations in the industry are doing these days. It’s DNA where the scientist decides the sequence rather than nature deciding the sequence.
There is nothing in our position that would prevent recombinant DNA from being patented, but there is — it is the cases that if the patents are upheld, recombinant DNA is frustrated.
People can’t use pieces of the BRCA gene to recombine them and find new treatments and find new diagnoses and find new things that will advance medicine and science as a result of these patents. It’s a perfect example of what the point of the product of nature doctrine is.
JUSTICE SCALIA: Yes. But, of course, to profit from — from that recombinant DNA, you have to not just isolate the gene, but then you have to do something with it afterwards. So you really haven’t given us a reason why somebody would try to isolate the gene.
[. . .]
JUSTICE SCALIA: I mean, sure, yes, I can do stuff with it afterwards, but so can everybody else. What advantage do I get from being the person that or the company that isolated that — that gene. You say none at all.
MR. HANSEN: No, I think you get enormous recognition, but I don’t think -
JUSTICE SCALIA: Well, that’s lovely.
MR. HANSEN: But I think that we know that that’s sufficient. We know it’s sufficient with respect to these two genes. We also know it’s sufficient with respect to the human genome.
JUSTICE KENNEDY: Well, I’m not sure the Court can decide the case on — on that basis. I’m sure that there are substantial arguments in the amicus brief that this investment is necessary and that — and that makes sense. To say, oh, well, the taxpayers will do it, don’t worry, is I think an insufficient answer. As Justice Kagan’s follow-up questions indicated, I thought you might say, well, there are process patents that they can have, that this is sufficient . . . But I — I just don’t think we can decide the case on the ground, oh, don’t worry about investment, it’ll come. I — I just don’t think we can do that. It may be that the law allows you to prevail on the fact that this is — occurs in nature and there’s nothing new here, but that’s quite different.
MR. HANSEN: And it is certainly true, as Your Honor suggests, that one of the incentives here is a process patent or a development patent. If you — if you’ve isolated the gene and you find a new use for it, you could get a patent on the new use for the patent.
JUSTICE SOTOMAYOR: That’s the whole point, isn’t it? The isolation itself is not valuable; it’s the use you put the isolation to. That’s the answer, isn’t it?
MR. HANSEN: That’s exactly correct. Thank you. Yes, that is the answer.
JUSTICE SOTOMAYOR: And so, that is the answer, which is in isolation it has no value. It’s just nature sitting there.
MR. HANSEN: Interestingly, it has one value. And that is you can look at it to see if there’s a mutation in it. And when you find a mutation in the isolated gene, you write back to the woman who provided the sample and you say to her: Because the isolated gene is the same as the gene in your body, I can tell you that there’s a mutation in your body.
JUSTICE SOTOMAYOR: That’s a failure of the patent law. It doesn’t patent ideas.
MR. HANSEN: And it shouldn’t patent ideas, and — but it also makes the point that isolated gene and the gene in the body are the same.
Justice Sotomayor appeared to lean toward the U.S. Government “compromise” position that isolated DNA should not be patentable, but that cDNA could be. She asserted that cDNA is not a product of nature, but is a human invention created in a lab. Justice Breyer also noted the differences between cDNA and that found in nature. When Mr. Hansen noted that “the question is not whether it is identical to something in nature. The question is whether there was a human invention involved, whether it is markedly different from what is found in nature.” Justice Sotomayor responded that such a difference lends itself to a 103 question of obviousness, rather than a Section 101 question regarding patentability. A good portion of the questions asked to Mr. Hansen involved the patent eligibility of cDNA, perhaps a signal that the Court is looking for a way to take the Government’s position and reject isolated DNA but accept cDNA as patentable.
Oral Argument of the United States as Amicus
Solicitor General Donald B. Verrilli followed Mr. Hansen, arguing on behalf of the United States in support of neither party, and was granted ten minutes to speak. As noted above, the U.S. Government position is to reject the patent eligibility of isolated DNA, but to permit patenting of cDNA. General Verrilli explained his understanding of why isolated DNA should be excluded from patent eligibility but cDNA should be included:
GENERAL VERRILLI: I actually think that — I think we’re — we’re fighting about something of importance. That question gets right to it. I want to answer the question directly, Your Honor. I’d like to make a prefatory point before doing so.The claim that isolated DNA is a human invention rests entirely on the fact that it is no longer connected at the molecular level to what surrounded it in the body. But allowing a patent on that basis would effectively preempt anyone else from using the gene itself for any medical or scientific purpose. That is not true about a patent on cDNA. A patent on cDNA leaves the isolated DNA available for other scientists and other — and others in the medical profession to try to generate new uses.
JUSTICE KAGAN: Mr. Hansen — Mr. Hansen just said that to do recombinant technology, you have to use the cDNA rather than the native D — the isolated DNA. Do you disagree with that?
GENERAL VERRILLI: That’s not my understanding, Justice Kagan. My understanding is that you — that the native DNA can be used for recombinant DNA without the step of cDNA. We do think cDNA is important and the position of the United States is that cDNA is patent eligible.
[. . .]
Our position, though, is that cDNA is patent eligible because we think, unlike the isolated DNA which is just taken from your body, cDNA is an artificial creation in the laboratory that doesn’t correspond to anything in your body.
JUSTICE GINSBURG: But Mister — General Verrilli, I got the distinct impression from your brief that your view was that, although the cDNA may be patentable, it might very well be rejected as obvious.
GENERAL VERRILLI: That’s true now, Justice Ginsburg, but obviousness is determined at the time that the patent is issued, so what may be true now might not have been true at the time the patents were initially issued. [. . .]
CHIEF JUSTICE ROBERTS: But I — I thought the basic general approach here was we have a very expansive view of what is patent eligible and then we narrow things through things — issues like obviousness and so on. Why — wouldn’t it make more sense to address the questions at issue here in the obviousness realm? [. . .] If you got something that’s big, it seems to me pretty obvious that you could take a smaller part of it; that the idea — a smaller part of something that’s bigger is obvious. Now, yes, you can have a patent on the process of extracting that small part, but I don’t understand how a small part ofsomething bigger isn’t obvious. And if it is, I don’t understand why this — these issues aren’t addressed at that stage.
GENERAL VERRILLI: Well, I think my answer to that, I guess, Your Honor, would — would point first to Mayo, in which the Court recognized that the threshold test under Section 101 for patent eligibility does do work that the obviousness test and a novelty test and a specification test do not do; and the work that it does here, I would respectfully submit, is to ensure that the natural substance, the product of nature itself, is not subjected effectively to a monopoly, because if it can be deemed to be a human invention solely as a result of the change that occurs when you extract it from the body, then that means, as a — as a practical matter that you have granted a patent on the gene itself because no one else can extract it because extracting it is isolating it; isolating it violates the patent. And so as a result of that, no one else can try to develop competing tests for breast cancer, no one else can try to use this gene for recombinant DNA.
CHIEF JUSTICE ROBERTS: I’m — I’m not sure that’s responsive to my concern. Your answer said well, here are a lot of reasons why this shouldn’t have patentprotection. My question goes to whether we ought to focus on those reasons at the eligibility stage or at the obviousness stage.
GENERAL VERRILLI: Well, the Court identified in Chakrabarty and then reiterated in Mayo that — that it is — that the right answer to that question, Your Honor, is to focus on them at the eligibility stage, because the — because getting the balance right is of critical importance.
JUSTICE ALITO: Well, the issue here is a very difficult one. It’s one on which the Government has changed its position; isn’t that correct?
GENERAL VERRILLI: Yes, Your Honor.
JUSTICE ALITO: It seems that there is disagreement within the Executive Branch about it. This case has been structured in an effort to get us to decide this on the broadest possible ground, that there’s no argument, that it’s just about 101, it’s not about any other provision of the Patent Act. Why — why should we — why should we do that? We have claims that if patent eligibility is denied here it will prevent investments that are necessary for the development of new drugs or it will lead those who develop the new drugs, new diagnostic techniques, to keep those secret, not disclose them to the public. Why — why should we jump in and — and decide the broadest possible question?
GENERAL VERRILLI: Well, I would — again, I would point the Court to what the Court said last term in Mayo, which is that the determination of patent eligibility really is a double-edged sword. And it may be that in a — in a particular case, maybe this case, although we are not expressing a view on it, you could sort the issue out on some of the other criteria, but that won’t generally be true, and the proposition of whether you can patent the gene itself is a question we think of fundamental importance, and it raises exactly the two-edged sword concern that led the Court to conclude what it did in Mayo.
Justice Ginsburg, as she did during oral arguments in the Kirtsaeng case (involving international exhaustion of copyrighted goods), raised questions on how other countries treat the same issue. Justice Ginsburg seems to have concerns regarding reaching decisions that would put the United States position at odds with other countries:
JUSTICE GINSBURG: General Verrilli, there’s an assertion made in Respondents’ brief that the United States would be in a singular position. That is, they suggest that in every other industrialized nation this could be subject — could be patentable. [. . .] Is that so?GENERAL VERRILLI: No. I think the picture is much more complicated than that. In many other nations it wouldn’t be patentable and the patent law is different from nation to nation.
I’ll give one example I think helps illustrate the point. In Germany and France, for example, you can get a patent on isolated genomic DNA but only for a particular use. So you would get what is the equivalent of a use patent, which is a patent that we would think under our patent laws is acceptable, too.
If you — just as with the question that Justice Alito asked earlier about identifying a — a useful substance in a plant in the Amazon, if you isolate that and it proves to have therapeutic effects, you can get a patent on that use of it, but what you can’t do is get a patent on the substance itself so that no one else can explore it for different uses and for – and for different therapeutic purposes or to try to recombine it and turn it into a — an even more therapeutic — therapeutically valuable substance.
When Justice Sotomayor raised a question regarding the patent eligibility of the cDNA claims at written in the present case, General Verrilli declined to answer, suggesting that it was a fight for the parties to have and not an issue for the United States as amici. General Verrilli, while arguing that cDNA itself may be patent eligible, did not argue that the cDNA claims-at-issue (as written in the case) are actually patentable.
At the conclusion of his time, General Verrilli again emphasized that the U.S. Government position is that one can receive a patent on a use, but not the thing (using the analogy that Justice Alito provided regarding a plant in the Amazon).
Oral Argument of Respondents (Myriad Genetics, et. al.)
Mr. Castanias opened his time for argument by asserting that isolated DNA has long been granted patents.
Justice Sotomayor quickly raised serious questions and concerns regarding the patent eligibility of Myriad’s claims:
JUSTICE SOTOMAYOR: I — I have a sort of analytical problem. I find it very, very difficult to conceive how you can patent a sequential numbering system by nature, in the same way that I have a problem in thinking that someone could get a patent on the computer binary code merely because they throw a certain number of things on a piece of paper in a certain order.I always thought that to have a patent you had to take something and add to what nature does. So how do you add to nature when all you are doing is copying its sequence? [. . .] How do you add to it besides process or use?
MR. CASTANIAS: Sure. Well, Justice Sotomayor, I guess I’ll take issue with the notion that there is nothing additive here. What Myriad inventors created in this circumstance was a new molecule that had never before been known to the world. Now remember, genes are themselves human constructs. And this points up some of the serious analytical problems with the Product of Nature Doctrine as the line-drawing exercise that you’ve asked General Verrilli and Mr. Hansen to engage in has illustrated. Now, the line-drawing is what is the product of nature to start with? Is it me? Is it the genome? Is it the chromosome? Is it the — and the gene ultimately [. . .] is what was defined.
JUSTICE SOTOMAYOR: I can bake a chocolate chip cookie using natural ingredients — salt, flour, eggs, butter — and I create my chocolate chip cookie. And if I combust those in some new way, I can get a patent on that. But I can’t imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I’ve created a new use or a new product from those ingredients. [. . .] Explain to me -- why gene sequences, whether in the actual numbers, why gene sequences are not those basic products that you can’t patent.
MR. CASTANIAS: Okay. I’ll start by — by showing you how this is actually a different structure. It actually has an entirely different chemical name when you give it the C -
JUSTICE SOTOMAYOR: That’s the cDNA.
MR. CASTANIAS: No, no, no. That’s absolutely true with regard to the isolated molecule as well. Because if you were to write it out in those -those interminable chemical equations that we had to do in high school, it’s a “C” very different, “H” very different.
JUSTICE SOTOMAYOR: So I put salt and flour, and that’s different?
MR. CASTANIAS: Well, that is — that is the combination, yes, of two different things, and that’s sort of like — that’s sort of like -
JUSTICE SOTOMAYOR: So if I take them apart, now you can get a patent on the salt and now you can get a patent on the flour?
MR. CASTANIAS: Well, they were apart before, but they were both old. But that’s the problem with using the really simplistic analogies, with all due respect, Your Honor, about you know, like coal -
[. . .]
JUSTICE ALITO: Why is the chemical composition in the isolated DNA different? You were about to explain that.
MR. CASTANIAS: Yes, thank you, Justice Alito. It — it’s got 5,914 nucleotides. The genome itself has over 3 billion. It’s arranged in the way set forth — as set forth in the SEQ IDs number 1 and 2. Number 2 is the so-called genomic DNA, SEQ ID number 1 is the, as Justice Breyer understood, the cDNA molecule.
When you look at those particular sequences, there was invention in the decision of where to begin the gene and where to end the gene. That was not given by nature. In fact -
JUSTICE SCALIA: Well, well, well, well, this is something I was going to ask you. I — I assume that it’s true that — that those abridged genes, whatever you want to call them, do exist in the body. That they do exist. You — you haven’t created a type of gene that does — does not exist in the body naturally.
MR. CASTANIAS: But we’ve — I’ll — I’ll use my own simplistic analogy which we offered in our brief and which we offered to the lower court. A baseball bat doesn’t exist until it’s isolated from a tree. But that’s still the product of human invention to decide where to begin the bat and where to end the bat.
Justice Breyer turned to the declarations that had been submitted by scientists and researchers in the case. Ultimately, Justice Breyer pressed Mr. Castanias regarding a particular brief, asking whether what the scientists supporting the Petitioners, specifically Dr. Lander, were wrong in their assertions on how the science works, leading to a lengthy discussion regarding the science:
JUSTICE BREYER: Well, that’s true, but then you were saying something that I just didn’t understand, because I thought the — the scientists who had filed briefs here, as I read it, said it’s quite true that the chromosome has the BRCA gene in the middle of it and it’s attached to two ends. But also in the body, perhaps because cells die, there is isolated DNA. And that means that the DNA strand, the chromosome strand is cut when a cell dies, and then isolated bits get around, and there may be very few of them in the world, but there are some, by the laws of probability, that will in fact match precisely the BRCA1 gene. Now, have I misread what the scientists told us, or are you saying that the scientists are wrong?MR. CASTANIAS: Well, I will tell you that -
JUSTICE BREYER: I probably misread it. There’s a better chance that I’ve misread it. (Laughter.)
MR. CASTANIAS: Well, no, I think — I think you may have read some of the submissions correctly, Justice Breyer. [. . .] I think that’s a question of some dispute in this record.
JUSTICE BREYER: So, in other words, you’re saying that the Lander brief is wrong. [. . .] I want to know, because I have to admit that I read it and I did assume that as a matter of science it was correct. So I would like to know whether you agree, as a matter of science, that it is correct, not of law, but of science, or if you are disagreeing with it, as a matter of science.
MR. CASTANIAS: What I will tell you is that what are called pseudogenes -
JUSTICE BREYER: I’d like a yes or no answer.
MR. CASTANIAS: Yes. So the answer — I would say the answer is no, because there is no evidence -
JUSTICE BREYER: Was the answer no, you do not disagree with it? I wonder, I disagree or I do disagree?
MR. CASTANIAS: I do disagree with it with the following -
JUSTICE BREYER: As a matter of science.
MR. CASTANIAS: As a matter of science with the following — okay.
JUSTICE BREYER: Okay. Very well. If you are saying it is wrong, as a matter of science, since neither of us are scientists, I would like you to tell me what I should read that will, from a scientist, tell me that it’s wrong.
MR. CASTANIAS: You want me to tell you something from a scientist that you should read that tells you that it is wrong?
JUSTICE BREYER: No, I need to know -
MR. CASTANIAS: I think you could look at the declaration in the — the Joint Appendix for Dr. Kay, for example. Dr. Kay’s declaration appears at — starting at page 370. You’ll find an extensive discussion in there of the technology here and — and of the genetics.
But, Justice Breyer, just to explain the finishing thought, what — what Dr. Lander says in his brief is that these pseudogenes, which are un – undifferentiated fragments, exist in the body. What hasn’t been brought to the — to the forefront is something that is new and useful and available to the public for — for allowing women to determine whether they have breast or ovarian [. . .] mutations that are likely to result in cancer.
The baseball bat analogy was resurrected from the two rounds of oral arguments at the Federal Circuit. Chief Justice Roberts seemed skeptical that the analogy was a relevant to the present case:
CHIEF JUSTICE ROBERTS: My understanding -my understanding is that here, what’s involved, obviously through scientific processes, but we’re not talking about process. Here, what’s involved is snipping. You’ve got the thing there and you snip -
snip off the top and you snip off the bottom and there you’ve got it.The baseball bat is quite different. You don’t look at a tree and say, well, I’ve cut the branch here and cut it here and all of a sudden I’ve got a baseball bat. You have to invent it, if you will. You don’t have to invent the particular segment of the –of the strand; you just have to cut it off.
Mr. Castanias responded by suggesting that no one knew where to snip the gene before Myriad did so and it was therefore an inventive and additive process.
Justice Kagan raised Justice Alito’s hypothetical again, essentially forcing Mr. Castanias to concede that the hypothetical Amazon plant would, in fact, not be patentable.
JUSTICE KAGAN: Mr. Castanias, go back to Justice Alito’s plant in the Amazon, right, because it takes a lot of ingenuity and a lot of effort to actually find that plant, just as it takes a lot of effort and a lot of ingenuity to figure out where to snip on — on the genetic material.But are you — are you saying that you could patent that plant because it takes a lot of effort and a lot of ingenuity to find it?
MR. CASTANIAS: The plant itself, I think not, Justice Kagan, but I think the question that was -that was posed was whether I could take an extract from that plant.
JUSTICE KAGAN: Well, but can you patent the thing itself?
MR. CASTANIAS: The thing itself I would -in that hypothetical, I would say the answer is no.
JUSTICE KAGAN: Even though you know you have to extract the plant itself . . . from the Amazon forest.
MR. CASTANIAS: Ah, but you see, now you’re adding the manipulation -
JUSTICE KAGAN: I’m not — I mean, I don’t know what manipulation means. I mean, you have to take the plant and uproot it, all right?
MR. CASTANIAS: Okay.
JUSTICE KAGAN: And carry it away and isolate it. Can you now patent the thing itself? You’ve now taken it out of the Amazon forest. Can you now patent it?
MR. CASTANIAS: Well, what I — what I haven’t done is isolated a new thing. All I have done is isolate the plant from the forest. And that’s the distinction I think I’m trying to get across to the Court, not particularly well at least in my colloquy with Justice Breyer, but I’ll try again. And that is that what — what was, quote, merely snipped out of the body here is fundamentally different in kind from what was in — what is in the body. The most important reason it’s different in kind is that it cannot be used in the body to detect the risk of breast and ovarian cancers.
JUSTICE KAGAN: Well, the plant in the forest can’t be used for any purpose either. It only has a use when it’s taken out — you know, when it’s uprooted and taken out of the forest. But it’s still the same thing. And I guess what you haven’t gotten me to understand is how this is different than that. It’s still the same thing, but now that you’ve isolated it, it in fact has lots of great uses.
MR. CASTANIAS: Well, I think there are two ways — two ways to look at that. First of all, if you want to look at it from the — the perspective of the so-called product of nature doctrine, which I think has some very dangerous consequences if it’s not cabined and understood correctly — but if you look at it strictly from a product of nature doctrine, you could say, well, that’s the same plant and it says in the 1930 legislative history of the Plant Patent Act that plants that are unmanipulated by the hand of man are not eligible for patents, and that’s fine, in terms of their breeding and genetics and that sort of thing. But the product of nature doctrine is troublesome for this reason: Modern medicine — go beyond just the isolated DNA patents here. Modern medicine, particularly the area of personalized medicine, is trying to get to a point where what we are administering to individual patients is giving them the opportunity to mimic the actions of the body. And — so actually, the goal of medicine is to get closer to nature, rather than farther away. And anything that takes the product of nature doctrine beyond the simple truism that the product of nature is something that is not a human invention, then that’s very dangerous, not just for our case -
[. . .]
JUSTICE BREYER: All right. So, when you are on that, that’s good. A more basic question to me is when you use the word “dangerous.” I had thought - and you can — I’d be interested in your view — that the patent law is filled with uneasy compromises, because on the one hand, we do want people to invent; on the other hand, we’re very worried about them tying up some kind of whatever it is, particularly a thing that itself could be used for further advance.
And so that the compromise that has been built historically into this area is: Of course, if you get a new satisfying process to extract the sap from the plant in the Amazon, patented. Of course, if you get the sap out and you find that you can use it, you manipulate it, you use it, you figure out a way to use it to treat cancer, wonderful, patented. But what you can’t patent is the sap itself.
Now, in any individual case that might be unfortunate or fortunate. But consider it in the mine run of things. It’s important to keep products of nature free of the restrictions that patents there are, so when Captain Ferno goes to the Amazon and discovers 50 new types of plants, saps and medicines, discovers them, although that expedition was expensive, although nobody had found it before, he can’t get a patent on the thing itself. He gets a patent on the process, on the use of the thing, but not the thing itself.
Mr. Castanias again tried to strengthen his case by noting that the USPTO has long granted patents on genes. Justice Ginsburg responded by pointing out that the Solicitor General was there to argue against the granting of patents on isolated DNA, signaling a shift in the position of the Executive Branch and therefore any presumption of validity or deference to the agency is diluted.
Justice Kagan turned back to the heart of the case and asked whether Mr. Castanias believes that chromosomes could have been patented. Justice Breyer resurrected a hypothetical from the Federal Circuit regarding whether human organs, removed from the body, could be patented.
JUSTICE KAGAN: I’m sorry, because -because — because, like Justice Breyer, I consider uses — patents on uses in a different category. So I’m just asking, could you patent the isolated chromosome?MR. CASTANIAS: Again, I — I perhaps am not making myself as clear as I should. In Section 101, a patent claim must be shown to be useful; and that -that is a utility that it has to be shown -
JUSTICE KAGAN: Yes. Chromosomes are very useful.
MR. CASTANIAS: — in any case.
(Laughter.)
JUSTICE KAGAN: The first person who found a chromosome and isolated it, I think we can all say that that was a very useful discovery. And the question is, can you then — can the person who found that chromosome and isolated it from the body, could they have gone to the PTO? . . .And the PTO seems very patent happy, so could, you know, would — would they have had a good patentability argument?
MR. CASTANIAS: I think if — to get through the Section 101 gateway, if that chromosome had a specific substantial and credible utility, in other words, it could be used in some -
JUSTICE KAGAN: Yes, of course it does.
MR. CASTANIAS: — diagnostic way in the way that we’re talking about here, then yes, it would pass through the Section 101 gate. Whether it would pass through the Section 102 gate or the 103 gate, I don’t have any opinion on –
[. . .]
JUSTICE KAGAN: And that’s interesting - [. . .]because then it’s not a question about, you know breaking these covalent bonds or whatever Judge Lourie thought it was about. Right? So, you know, if — if not DNA, if — if not the — the more smaller unit in the chromosome, you know, we could just go up from there and talk about all kinds of parts of the human body, couldn’t we? Couldn’t we get to, you know, the first person who found a liver?
MR. CASTANIAS: I — I think — I think, Justice Kagan, you’re really putting your finger on the problem with this, again, I — I keep wanting to refer to as the so-called Product of Nature Doctrine because I don’t believe that as a separate doctrine it really exists. It’s just the flip side of the coin of something that shows a lack of invention. And, of course, that’s where Section 103 comes into full force as the Chief Justice mentioned earlier in the argument. Section 103 allows you to make comparisons to what was old and what was new. I don’t think the organ, the liver, gets past 103 in that circumstance even if you say, well -
JUSTICE BREYER: You are saying it gets past 101.
MR. CASTANIAS: Even if it gets through the 101 -
JUSTICE BREYER: Well, that’s — that’s the problem. I mean, all parts of the human body? Anything from inside the body that you snip out and isolate?
MR. CASTANIAS: No.
JUSTICE BREYER: And it gets through 101? Does it have to — I mean, that’s actually what’s bothering me.
MR. CASTANIAS: Okay. So let — let me try to help you with that. Because — because the distinction is between the liver or the kidney, which was the one brought up in the federal circuit opinion, but liver, kidney, you know, gallbladder, pick your organ. But it’s the same thing. It is the same thing when it’s inside the body and it’s out. That’s where our -
JUSTICE SOTOMAYOR: But you’re not suggesting if you cut off a piece of the liver or a piece of the kidney that that somehow makes that piece patentable.
MR. CASTANIAS: No. Absolutely not. It’s the same thing.
JUSTICE SOTOMAYOR: So what’s the difference? I mean, if you cut off a piece of the whole in the kidney or liver, you’re saying that’s not patentable, but you take a gene and snip off a piece, that is? What’s the difference between the two -
MR. CASTANIAS: I would say that — I would say that under — under your existing decisions in
Chakrabarty, J.E.M., that set forth a broad understanding of Section 101 and an understanding of what is within the limited exception, then what — I — I would — I mean, honestly, I think that Section 103 does this work better than Section 101, but to the point of Section 101, there’s — there is nothing different about that piece in the body.JUSTICE BREYER: Ah. Then — then watch what you’re doing. That’s very, very interesting, because, really, we are reducing, then, 101 to anything under the sun, and — and that, it seems to me, we’ve rejected more often than we’ve followed it. And particularly with a thing found in nature doctrine, because, of course, it doesn’t just -human kidneys and so forth. Everything is inside something else. Plants, rocks, whatever you want. And so everything will involve your vast taking something out of some other thing where it is, if only the environment. And it’s at that point that I look for some other test than just that it was found within some other thing
MR. CASTANIAS: And I think, Justice Breyer, there is where I’ve — I’ve tried to explain to you about the different functions, the different values. If you think about patents as economic instruments, the different economic values that come out of this, the different things that patients now have as a result of this human ingenuity, they didn’t have the BRCA1 isolated gene before the Myriad invention.
JUSTICE KENNEDY: Well, we could have said that with atomic energy, with electric, but so far the choice — electricity — but so far the choice of the patent was that we have a uniform rule for all industries.
Mr. Castanias tried to analogize the present case to medicines, asserting that medicines are simply molecules. Chief Justice Roberts quickly refuted that point:
MR. CASTANIAS: [. . .] And I think one last point to close on. It’s important to note that molecules have been patented for a very long time. That’s what drugs are. And drugs are often made by taking one molecule and another molecule, both of which are known, reacting them in a test tube, which is a very common thing, reactions have been around 100 years just like snipping has been, but they make something new and useful and life saving from that.CHIEF JUSTICE ROBERTS: Well, I don’t understand how this is at all like that, because there you’re obviously combining things and getting something new. Here you’re just snipping, and you don’t have anything new, you have something that is a part of something that has existed previous to your intervention.
Rebuttal of Petitioners
Immediately during Mr. Hansen’s rebuttal time, Justice Sotomayor asked whether there would be any benefit to striking down the patent on isolated DNA, but permitting patenting of cDNA:
MR. HANSEN: Of — of course there would be value in that in the sense that — that, A, it reinforces the Product of Nature Doctrine, but more importantly, the effect of the patents in this case allows Myriad to stop all research on a part of the human body. If you uphold the patents in this case, Myriad can — has the authority given it by the Government to stop anyone from doing research on a piece of the human body. That would be a significant advance, if you were to — to make it clear that was impermissible.